Onsite QA Specialist – GMP & Documentation Lead

Kamau Therapeutics, Inc.; South San Francisco (CA); On-site; USD 100,000 - 135,000; Full time

Benefits offered by this job

Health, dental, and vision coverage

Retirement benefits

Paid time off

Annual target bonus

Equity in stock options

Job summary

The successful candidate will collaborate across functions, drive processes that ensure QA rigor, and help shape our inspection readiness program. A BS in a life science or related field with 2–5 years GMP QA experience is required, along with familiarity with eQMS platforms and external CDMO workflows. Kamau offers a comprehensive Total Rewards package and a target bonus, with five days onsite per week and travel mostly within the US.

Qualifications

• BS in life science, engineering, or related field with 2-5 years GMP quality assurance experience.
• Hands-on batch-record review and deviation investigations/CAPA documentation.
• Familiarity with eQMS and validated EDMS platforms (Dot Compliance, Veeva, MasterControl, TrackWise, Qualio or equivalent), controlled document lifecycles, and external approval workflows with CDMO partners.
• Strong attention to detail, ability to manage high volume of documentation accurately in a fast-paced, scaling environment.

Responsibilities

• Perform batch-record review for CDMO GMP manufacturing runs.
• Author SOPs and WKIs for various internal procedures to support CDMO functions.
• Own specification version control and reconcile release data against the effective product specifications.
• Support deviation, CAPA, and change-control documentation and tracking as lot volume increases through PPQ.
• Support review and approval of CDMO-authored test methods, method transfer and qualification protocols, and test data records.
• Support inspection-readiness activities ahead of BLA, including documentation organization and gap assessments.
• Support deployment and day-to-day administration of the electronic quality management system (Dot Compliance).
• Support vendor and CDMO quality accountability, including quality agreement adherence, supplier quality documentation review.
• Track quality metrics and documentation status across manufacturing campaigns, and support quality-related sections of CMC documentation as needed.
• Assist with document control, training coordination, and SOP maintenance as the quality function scales.

Skills

Batch-record review

Deviation investigations

CAPA documentation

eQMS

CDMO workflows

Veeva

MasterControl

TrackWise

Qualio

Document control

Attention to detail

Education

BS in life science

Tools

Dot Compliance

Veeva

MasterControl

TrackWise

Qualio

Job description

The successful candidate will collaborate across functions, drive processes that ensure QA rigor, and help shape our inspection readiness program. A BS in a life science or related field with 2–5 years GMP QA experience is required, along with familiarity with eQMS platforms and external CDMO workflows. Kamau offers a comprehensive Total Rewards package and a target bonus, with five days onsite per week and travel mostly within the US.